Headgear connection assembly for a respiratory mask

ABSTRACT

A respiratory mask assembly for delivering breathable gas to a patient includes a frame and at least one locking clip. The frame has a main body and a side frame member provided on each lateral side of the main body, at least one of the side frame members including a locking clip receiver assembly. The at least one locking clip has a main body providing a front portion adapted to be removably coupled with the at least one locking clip receiver assembly and a rear portion adapted to be removably coupled to a headgear assembly. The rear portion includes a cross bar that forms an opening through which a strap of the headgear assembly can pass and be removably coupled with the cross bar, and the front portion includes at least one resiliently flexible spring arm that is flexible within the plane of the main body.

CROSS-REFERENCE TO PRIORITY APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication Ser. No. 60/424,698 filed Nov. 8, 2002 and U.S. ProvisionalApplication Ser. No. 60/467,571 filed May 5, 2003; and the presentapplication is a Continuation-In-Part of U.S. Non-Provisionalapplication Ser. No. 10/235,846 filed Sep. 6, 2002, which in turn claimspriority to U.S. Provisional Application No. 60/317,486 filed Sep. 7,2001 and U.S. Provisional Application Ser. No. 60/342,854 filed Dec. 28,2001. Each of the above applications is hereby incorporated herein byreference in its entirety.

FIELD OF THE INVENTION

The present invention relates to a headgear connection assembly for usein removably attaching a headgear assembly to a frame of a respiratorymask assembly, the mask assembly being used for treatment, e.g., ofSleep Disordered Breathing (SDB) with Non-invasive Positive PressureVentilation (NPPV).

BACKGROUND OF THE INVENTION

Respiratory mask assemblies used in the treatment of SDB may comprise anasal mask designed to fit over a patient's nose, or a full face maskdesigned to fit over the nose and mouth of the patient. Air or otherbreathable gas is supplied by a blower and passed along a flexibleconduit to the mask assembly.

The mask assembly generally comprises a relatively rigid shell, e.g., aframe, which defines a rearwardly opening cavity covering the patient'snose and/or mouth, and a soft portion, e.g., a cushion, which spaces theframe away from the face of the patient for comfortable contact.

The mask assembly is usually held in place using a headgear assembly,the frame and headgear assembly being joined using some form ofconnector.

One form of known connector is described in U.S. Pat. No. 6,374,826(Gunaratnam et al.). The contents of this patent are hereby incorporatedby reference.

Some patients have poor dexterity, and hence find certain arrangementsof connectors awkward or difficult to use. For example, some patientsmay have difficulty in correctly joining the frame and headgear assemblywith the connector. As a result, the connector may disengage during useor may become stuck so it becomes difficult for the patient todisconnect the frame from the headgear assembly.

Furthermore, some connectors are positioned on the frame of the maskassembly which makes it difficult for the user to see the connectors,because they are very close to the eyes or out of the range of vision ofthe patient. Hence, it is important to have a connector which is easy touse and which is easy to correctly assemble even if it is out of therange of vision of the patient.

SUMMARY OF THE INVENTION

One aspect of the present invention is to provide a respiratory maskassembly having a headgear connection assembly positioned between theframe and headgear assembly in a convenient and intuitive location forquick attachment and/or detachment by the patient, while not beingeasily detached accidentally.

Another aspect of the present invention provides a respiratory maskassembly for delivering breathable gas to a patient. The respiratorymask assembly according to one embodiment includes a frame and at leastone locking clip. The frame has a main body and a side frame memberprovided on each lateral side of the main body. At least one of the sideframe members includes an integrally formed locking clip receiverassembly. The at least one locking clip has a main body providing afront portion and a rear portion. The front portion is adapted to beremovably coupled with the at least one locking clip receiver assemblyand the rear portion is adapted to be removably coupled to a headgearassembly. The rear portion of the locking clip includes a cross bar thatforms an opening through which a strap of the headgear assembly can passand be removably coupled with the cross bar, and the front portion ofthe locking clip includes at least one resiliently flexible spring armthat is flexible within the plane of the main body.

Another aspect of the invention is to provide a headgear connectionassembly which can be easily molded in a mask frame which includes aswivel elbow connector.

Other aspects, features and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a front perspective view illustrating a mask assembly having aheadgear connection assembly constructed in accordance with anembodiment of the invention;

FIG. 2 is a front view of the mask assembly showing FIG. 1;

FIG. 3 is a top view of a locking clip of the headgear connectionassembly shown in FIG. 1;

FIG. 4 is a perspective view of a locking clip of the headgearconnection assembly shown in FIG. 1;

FIG. 5 is a perspective view of a locking clip receiver assembly of theheadgear connection assembly shown in FIG. 1;

FIG. 6 is a front view of a locking clip receiver assembly of theheadgear connection assembly shown in FIG. 1;

FIG. 7 is a cross-sectional view of a locking clip receiver assembly ofthe headgear connection assembly shown in FIG. 1;

FIG. 8 is a cross-sectional view illustrating the engagement between alocking clip and a locking clip receiver assembly of the headgearconnection assembly shown in FIG. 1;

FIG. 9 is a cross-sectional view illustrating the engagement between alocking clip and a locking clip receiver assembly of the headgearconnection assembly shown in FIG. 1;

FIG. 10 is a perspective view illustrating the mask assembly of FIG. 1being secured to a patient's face by a headgear connection assembly ofFIG. 1;

FIG. 11 is a top view illustrating the headgear connection assembly ofFIG. 1 in a first incorrect position with respect to the frame of themask assembly;

FIG. 12 is a top view illustrating the headgear connection assembly ofFIG. 1 in a second incorrect position with respect to the frame of themask assembly;

FIG. 13 is a front perspective view of a locking clip of the headgearconnection assembly shown in FIG. 1;

FIG. 14 is a rear perspective view of the locking clip shown in FIG. 13;

FIG. 15 is a top view of the locking clip shown in FIG. 13;

FIG. 16 is a cross-section taken along line 16-16 of FIG. 15;

FIG. 17 is a front view of the locking clip shown in FIG. 13;

FIG. 18 is a rear view of the locking clip shown in FIG. 13;

FIG. 19 is a side view of the locking clip shown in FIG. 13;

FIG. 20 is a bottom view of the locking clip shown in FIG. 13;

FIG. 21 is a front perspective view of another embodiment of a lockingclip;

FIG. 22 is a rear perspective view of the locking clip shown in FIG. 21;

FIG. 23 is a top view of the locking clip shown in FIG. 21;

FIG. 24 is a cross-section taken along line 24-24 of FIG. 23;

FIG. 25 is a front view of the locking clip shown in FIG. 21;

FIG. 26 is a rear view of the locking clip shown in FIG. 21;

FIG. 27 is a side view of the locking clip shown in FIG. 21;

FIG. 28 is a bottom view of the locking clip shown in FIG. 21;

FIG. 29 is a front perspective view illustrating an embodiment of aframe for a full-face mask assembly, the frame having a locking clipreceiver assembly structured to interlock with the locking clip shown inFIG. 21;

FIG. 30 is a front perspective view, similar to FIG. 29 but at adifferent angle, of the frame shown in FIG. 29;

FIG. 31 is a rear perspective view of the frame shown in FIG. 29;

FIG. 32 is a front view of the frame shown in FIG. 29;

FIG. 33 is a side view of the frame shown in FIG. 29;

FIG. 34 is a top view of the frame shown in FIG. 29;

FIG. 35 is a top perspective view illustrating an embodiment of aforehead support adapted to be movably mounted to an upper portion ofthe frame shown in FIG. 29, the forehead support having a locking clipreceiver assembly structured to interlock with the locking clip shown inFIG. 21;

FIG. 36 is a rear perspective view of the forehead support shown in FIG.35;

FIG. 37 is a front perspective view of the forehead support shown inFIG. 35;

FIG. 38 is a front view of the forehead support shown in FIG. 35;

FIG. 39 is a side view of the forehead support shown in FIG. 35; and

FIG. 40 is a top view of the forehead support shown in FIG. 35.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIGS. 1 and 2 shown a respiratory mask assembly 10 that includes a frame12 and a cushion 14 that may be permanently or removably connected tothe frame 12. For example, the cushion 14 may be removably attached tothe frame 12 with a cushion clip, straps, a friction or interferencefit, and/or a tongue-in-groove arrangement, as is known in the art.However, the cushion 14 may be permanently attached to the frame 12 withglue and/or mechanical fastening means, for example.

A forehead support 16 is movably mounted to an upper portion of theframe 12. A headgear assembly (not shown) can be removably attached tothe frame 12 to maintain the frame 12 and cushion 14 in a desiredadjusted position on the patient's face. For example, the headgearassembly may include a pair of upper and lower straps with the upperstraps removably connected to clip structures 18 provided on theforehead support 16 and the lower straps removably connected the frame12 by a headgear connection assembly 20, as will be further discussedbelow.

In the illustrated embodiment, the mask assembly 10 is a nasal maskstructure to deliver breathable gas to a patient's nose. However, themask assembly 10 may be a nasal and mouth mask, or the mask assembly maybe a full face mask.

A swivel elbow assembly 22 is removably attached to a front portion ofthe frame 12. The elbow assembly 22 is structured to be connected to aconduit that is connected to a pressurized supply. The pressurizedsupply supplies pressurized breathable gas through the conduit and elbowassembly 22 and into the cushion 14 for breathing by the patient.

In the illustrated embodiment, lower straps of the headgear assembly areremovably attached to the frame 12 by a headgear connection assembly 20.The headgear connection assembly 20 includes a first connector portion24 provided by the frame 12 and a second connector portion 26 adapted tobe removably coupled with the first connector portion 24. The secondconnector portion 26 is removably connected to the lower straps of theheadgear assembly.

As shown in FIGS. 1-2, the second connector portion 26 includes a pairof locking clips 28. In a preferred embodiment, the locking clip 28 is aunitary plastic piece formed by injection molding. As shown in FIGS. 3and 4, each locking clip 28 includes a main body 30 having a rearportion 32 and a front portion 34. The rear portion 32 is removablyconnected to a lower strap of the headgear assembly and the frontportion 34 is removably coupled with the first connector portion 24provided on the frame 12.

Specifically, the front portion 34 includes at least one and preferablytwo resiliently flexible spring arms 36 that are attached to oppositesides of the main body 30 and extend away from the main body 30 in agenerally parallel manner. However, the front portion 34 may include onespring arm 36. The spring arms 36 can flex up and down, e.g., in thedirection of arrows A or in a reverse direction of arrows A,respectively, as shown in FIG. 3. A locking tab 38 is attached to a freeend of each spring arm 36. Further, each spring arm 36 is configured toprovide a shoulder portion 40. In use, the shoulder portions 40 andlocking tabs 38 are adapted to engage with corresponding portions of thefirst connector portion 24 for coupling the first and second connectorportions 24, 26 with one another. For example, the locking tabs 38 arestructured to prevent accidental disengagement of the second connectorportion 26 from the first connector portion 24 if a force is applied tothe second connector portion 26 in the direction of arrow B (FIG. 3), aswill be further discussed.

The front portion 32 also includes a central support tab 42 positionedbetween the pair of spring arms 36. In the illustrated embodiment, thecentral support tab 42 has a length that is greater than the length ofeach of the spring arms 36. The central support tab 42 is slidablyinsertable into a complimentary shaped portion of the first connectorportion 24, as will be further discussed.

As shown in FIG. 4, the central support tab 42 includes a groove 44. Thecentral support tab 42 has a height of h2, and the front portion of eachspring arm 36 has a height of h1. In the illustrated embodiment, theheight h2 is larger than the height h1. In an alternative embodiment, h2may be smaller than h1.

The rear portion 32 of the second connector portion 26 includes a crossbar 46 that forms an opening 48 through which a lower strap of theheadgear assembly may pass and be removably connected. Specifically, anend portion of the lower strap of the headgear assembly may be wrappedaround the cross bar 46. Fastening of the lower strap to the cross bar46 may be assisted by use of a hook and loop material, such as Velcro®.Thus, the lower strap may be adjusted with respect to the locking clip28 for proper fit. The locking clip 28 may be rotatably adjustable withrespect to the headgear assembly, e.g., see U.S. Provisional ApplicationNo. 60/402,509, filed on Aug. 12, 2002, incorporated herein by referencein its entirety.

As shown in FIGS. 1, 2, and 5, the frame 12 includes a main body 50accommodating the cushion 14 and a side frame member 52 provided on eachlateral side of the main body 50. Each side frame member 52 includes thefirst connector portion 24 which is integrally formed therewith. Asshown in FIGS. 5-7, the first connector portion 24 includes a lockingclip receiver assembly 54. The locking clip 28 is structured tointerlock with the locking clip receiver assembly 54 to removably attachthe locking clip 28, and hence the headgear assembly, to the frame 12.

Each locking clip receiver assembly 54 includes a slot 56 having acentral portion 58 and two locking portions 60 positioned on oppositesides of the central portion 58. The central portion 58 of the slot 56has an upper surface 62 that is continuous with an upper surface 64 ofeach of the locking portions 60. However, lower surfaces 66, 68 of thecentral portion 58 and two locking portions 60, respectively, have astepped configuration. Specifically, as shown in FIGS. 5 and 6, thecentral portion 58 has a height h2 between the upper surface 62 andlower surface 66 thereof. The two locking portions 60 have a height h1between the upper surface 64 and lower surface 68 thereof. In theillustrated embodiment, the height h2 is greater than the height h1.Moreover, the height h2 of the central portion 58 is approximately equalto the height h2 of the central support tab 42 and the height h1 of thetwo locking portions 60 is approximately equal to the height h1 of thefront portion of each spring arm 36. This arrangement facilitates theconnection between the locking clip 28 and the locking clip receiverassembly 54, as will be further discussed.

As shown in FIG. 7, each of the locking portions 60 includes a lockingflange 70 positioned on an outer wall thereof for engagement with thelocking tab 38 of a locking clip 28.

The central portion 58 includes a wall 72 that extends upwardly from thelower surface 66 towards the upper surface 62. In the illustratedembodiment, the wall 72 extends approximately half the way to the uppersurface 62.

In the illustrated embodiment, the first connector portions 24 areintegrally molded with the frame 12. As shown in FIGS. 5 and 10, theframe 12 also includes an orifice 80 and collar 82 adapted to receive aswivel elbow 22 (FIGS. 1 and 2). The collar 82 has a rim 84 whichextends horizontally and radially from the orifice 80. In order to formthe collar 82, it is advantageous if the mold can be withdrawnhorizontally. However, it is desirable that the headgear be presented atan angle with respect to the frame 12. The first connector portions 24are aligned downwardly at an angle θ of approximately 5% with respect tothe horizontal. When the frame 12 is molded, the mold components shouldbe withdrawn in a horizontal direction to form the collar 82. As shownin FIG. 7, the junction between the lower surfaces 66, 68 of the centralportion 58 and locking portions 60, respectively, is arranged to make anangle α which is sufficiently wide to enable the sides of the mold to bewithdrawn in a horizontal direction. Further, the angled junctionfacilitates the connection between the locking clip 28 and the lockingclip receiver assembly 54.

As shown in FIG. 9, the front portion 34 and rear portion 32 of thelocking clip 28 are disposed at an angle β with respect to one another.In the illustrated embodiment, the rear portion 34 is angled downwardlywith respect to the horizontal, whereas the front portion 32 isgenerally horizontally aligned. By use of this angle, the locking clip28 does not protrude as far from the mask as it would otherwise.Furthermore, the headgear straps are connected to the locking clip 28 atan angle which more naturally follows the contour of the face. In analternative form of the invention, the front and rear portions 34, 32may be curved to achieve an angular difference between the front andrear. An advantage of either approach is that the slot 56 of the firstconnector portion 24 into which the front portion 34 of the secondconnector 26 is slidably received may be generally horizontal. This isadvantageous during the manufacture process because it means the sidesof the mold may be withdrawn horizontally to assist formation of thecollar 82.

As shown in FIGS. 8-9, the locking portions 60 of the slot 56 areadapted to receive a respective one of the pair of spring arms 36, thelocking tab 38 of each spring arm 36 interlocking with the lockingflange 70 provided in respective locking portions 60 to removably attachthe locking clip 28, and hence the headgear assembly, to the frame 12.The shoulder portion 40 of each locking clip 28 engages an engagementface 74 provided on the frame 12 when the locking clip 28 is insertedinto the locking clip receiver assembly 54 to provide additional supportfor the locking clip 28. The locking tab 38 may interlock with anundercut provided in the locking portions 60 to removably attach thelocking clip 28 to the frame 12. Further, each locking tab 38 may extendthrough a slot provided in the outer wall of the locking portion 60. Theslot need not extend through the outer wall of the locking portion 60.

The central support tab 42 is inserted into the central portion 58 ofthe slot 56 when the locking clip 28 and locking clip receiver assembly54 are engaged so as to prevent relative movement between the lockingclip 28 and the locking clip receiver assembly 54.

Specifically, when the locking clip 28 is inserted into the locking clipreceiver assembly 54, the spring arms 36 are forced toward one another(in the direction of arrows A as shown in FIG. 3) as the locking tabs 38are inserted into respective locking portions 60 of the slot 56 and rideup and over the locking flanges 70. Once the locking tabs 38 havecleared respective locking flanges 70, the spring arms 36 can springoutwardly (in the reverse direction of arrows A as shown in FIG. 3) toprovide a locking engagement between the locking tabs 38 and the lockingflanges 70. Sufficient clearance is provided in the locking portions 60of the slot 56 to allow the necessary movement of the locking tabs 38 toclear the locking flanges 70.

The central support tab 42 is configured to have a close fit with thecentral portion 58 of the slot 56 so that when the central support tab42 is inserted into the central portion 58, little rotational, rockingor side-to-side movement is permitted between the locking clip 28 andthe locking clip receiver assembly 54. The central support tab 42 islonger than the spring arms 36 to assist with alignment into the slot56. Further, the groove 44 of the central support tab 42 engages thewall 72 provided in the central portion 58 of the slot 56 to facilitateentry of the central support tab 42 into the central portion 58 of theslot 56. Alternatively, the central support tab 42 may have a protrusionthat engages a groove provided in the central portion 58 of the slot 56.Also, the central support tab 42 has a shape that is complementary tothe angle α that defines the shape of the central portion 58 of the slot56.

Because the height h2 of the central portion 58 is approximately equalto the height h2 of the central support tab 42 and the height h1 of thetwo locking portions 60 is approximately equal to the height h1 of thefront portion of each spring arm 36, the locking portions 60 of the slot56 are of sufficient height to accommodate the front portion of eachspring arm 36, but insufficient to accommodate the central support tab42. That is, the central support tab 42 is too thick to fit into thelocking portions 60 of the slot 56. Because of this arrangement, it willbe clear to the patient whether or not the locking clip 28 has beencorrectly engaged with the locking clip receiver assembly 54. Thus, thepatient cannot inadvertently partly assemble the locking clip 28 to thelocking clip receiver assembly 54 in such a way that it willaccidentally release. For example, FIG. 11 illustrates a first incorrectposition of the locking clip 28 with respect to the locking clipreceiver assembly 54 and FIG. 12 illustrates a second incorrect positionof the locking clip 28 with respect to the locking clip receiverassembly 54. In both instances, the patient is unable to insert thethicker central support tab 42 into the thinner locking portion 60 ofthe slot 56.

To release the locking clip 28 from the locking clip receiver assembly54, the patient simply forces the spring arms 36 towards one another toclear the locking tabs 38 from respective locking flanges 70. Then, thepatient pulls the locking clip 28 outwardly away from the frame 12 todisengage the locking clip 28 from the locking clip receiver assembly54.

As shown in FIG. 8, the locking tabs 38 and central support tab 42 haverounded or contoured edges to facilitate entry into the slot 56. Also,the outward surfaces of the locking clip 28 and the frame 12 preferablyform a generally coextensive continuous surface, which is notinterrupted when connected. Preferably, the locking clip 28 is as wideas the side frame members 52, which facilitates tactile location of thelocking clip 28 by the patient.

The spring arms 36 are designed to flex within the plane of the lockingclip main body 30, which further improves the ease by which the lockingclips 28 are attached and detached. This positioning improves theergonomics of flexing the spring arms up and down. As shown in FIG. 10,the patient's thumb and opposing finger can be used to readily locateand operate the locking clips 28. The outward surface of the spring arms36 may include a series of protrusions 76 to facilitate gripping of thelocking clip 28 by the patient (see FIG. 8). Further, the locking clips28 are connected to the straps of the headgear assembly so that lengthadjustment may be provided.

An advantage of the headgear connection assembly 20 is that one lockingclip 28 can be used with the locking clip receiver assembly 54 providedon each side frame member 52, thereby reducing manufacturing costs andthe need for inventory.

FIGS. 13-20 show further structural details in various dimensions in oneembodiment of the locking clip 28 of the headgear connection assembly20. For example, the locking clip 28 has a length in the range of 20-40mm, preferably 29 mm, a width in the range of 20-40 mm, preferably 27.8mm, and a height in the range of 4-8 mm, preferably 6.7 mm. In anembodiment of the locking clip 28, the dimensions illustrated in FIGS.13-20 may vary ±10%.

In the illustrated embodiment, the rear portion 32 of the locking clip28 includes a cross-bar 46 that forms an opening 48 through which astrap of the headgear assembly can be removably coupled with thecross-bar 46. In other forms of the invention, the strap of the headgearassembly is connected using other mechanisms. For example, the strap mayinclude a hook which engages with a corresponding hole in the lockingclip. In another form, the strap is sewn in position and is notremovable. In another form, the strap is removable, and held in positionby a friction fit.

In the illustrated embodiment, a locking clip in accordance with theinvention is used only on a mask frame adjacent a swivel elbow, in theregion of the mouth; and straps for connection to a forehead support ofthe mask assembly are held in position only by hook & loop material.Thus two locking clips are used on one mask. In another embodiment ofthe invention, four locking clips are used, two as illustrated, and afurther two being used as part of the forehead support.

FIGS. 21-28 illustrate another embodiment of a locking clip, indicatedas 228. As shown in FIGS. 29-40, the locking clip 228 is structured foruse with a full-face mask assembly having a frame 212 (see FIGS. 29-34)and a forehead support 216 (see FIGS. 35-40). Specifically, as shown inFIGS. 29-34, the frame 212 has a pair of locking clip receiverassemblies 254 structured to interlock with a pair of locking clips 228.As shown in FIGS. 35-40, the forehead support 216 has a pair of lockingclip receiver assemblies 254 structured to interlock with a pair oflocking clips 228. However, the locking clip 228 and locking clipreceiver assemblies 254 illustrated may be structured for use with anasal mask or a nasal and mouth mask, for example.

As shown in FIGS. 21-28, the locking clip 228 is substantially similarto the locking clip 28 described above. In contrast, the length of thegroove 244 provided in clip 228 is greater than the length of the groove44 provided in clip 28, as will be further discussed. The remainingelements of the locking clip 228 are similar to the elements of thelocking clip 28 and are indicated with similar reference numerals.

Similar to the previous embodiment, the locking clip 228 includes a mainbody 230 having a rear portion 232 and a front portion 234. The rearportion 232 is removably connected to a strap of the headgear assemblyand the front portion 234 is removably coupled with a respective lockingclip receiver assembly 254 provided on the frame 212 or forehead support216. The front portion 234 includes two resiliently flexible spring arms236 that are attached to opposite sides of the main body 230. Theflexible spring arms 236 are flexible within the plane of the main body230.

Further, each spring arm 236 includes a locking tab 238 and a shoulderportion 240 adapted to engage with a respective locking clip receiverassembly 254 provided on the frame 212 or forehead support 216. As bestshown in FIGS. 22 and 28, the front portion 234 also includes a centralsupport tab 242 that includes a groove 244.

The groove 244 provided in clip 228 is deeper or more elongated than thegroove 44 provided in clip 28 (as best shown in FIGS. 14 and 22). In theillustrated embodiment, the groove 244 has a length that is at leasthalf a length of the central support tab 242. The elongated groove inclip 228 facilitates with alignment of the clip 228 with the frame 212or forehead support 216. Moreover, the elongated groove 244 helps toprevent relative movement between the locking clip 228 and therespective locking clip receiver assembly 254 on the frame 212 orforehead support 216, as will be further discussed below.

FIGS. 29-34 show an embodiment of a frame 212 for a full-face maskassembly. The frame 212 may be permanently or removably connected to acushion (not shown) in any suitable manner. Further, a swivel elbowassembly (not shown) may be removable attached to a front portion of theframe 212.

Each lateral side of the frame 212 includes a locking clip receiverassembly 254 structured to interlock with a locking clip 228. Similar tolocking clip receiver assembly 54, the locking clip receiver assembly254 includes a slot 256 having a central portion 258 and two lockingportions 260. The locking portions 260 include a locking flange 270 (seeFIG. 32) positioned on an outer wall thereof for engagement with thelocking tab 238 of a locking clip 228. In the illustrated embodiment, anupper wall 261 of the slot 256 includes a pair of openings 263 that arealigned with the locking flange 270. This enables the patient tovisually confirm that the locking tab 238 of a locking clip 228 isinterlocked with the locking flange 270 in use.

Also, the central portion 258 includes a wall 272. As best shown inFIGS. 29, 30, and 32, the wall 272 provided in the locking clip receiverassembly 254 extends outwardly away from the slot 256. In the embodimentof locking clip receiver assembly 54, the wall 72 was positionedentirely within the slot 56 (see FIGS. 5, 7, 11, and 12). The elongatedwall 272 of locking clip receiver assembly 254 facilitates alignment ofa clip 228 with a respective locking clip receiver assembly 254.Specifically, the groove 244 of a clip 228 may be engaged with theelongated wall 272 so as to guide the clip 228 into the slot 256.

Moreover, when a clip 228 is engaged with a respective locking clipreceiver assembly 254, the engagement between the elongated groove 244of the clip 228 and the wall 272 of the locking clip receiver assembly254 prevents rocking or side-to-side movement between the clip 228 andlocking clip receiver assembly 254. Further, any force applied to one ofthe spring arms 236 of the clip 228, when the clip 228 is engaged withthe locking clip receiver assembly 254, will not be transferred to theother spring arm 236 of the clip 228. Thus, the clip 228 is preventedfrom being inadvertently disengaged from the respective locking clipreceiver assembly 254 in use. To release the locking clip 228 from thelocking clip receiver assembly 254, both spring arms 236 must be forcedtowards one another to clear the locking tabs 238 form respectivelocking flanges 270.

FIGS. 35-40 show an embodiment of a forehead support 216 adapted to bemovably mounted to an upper portion of the frame 212. The foreheadsupport 216 may be permanently or removably connected to a forehead pads(not shown) in any suitable manner.

Each lateral side of the forehead support 216 includes a locking clipreceiver assembly 254 structured to interlock with a locking clip 228.The locking clip receiver assembly 254 on the forehead support 216 issubstantially similar to the locking clip receiver assembly on the frame216 and indicated with similar reference numerals. As a result, onelocking clip 228 can be used with the locking clip receiver assemblies254 provided on the frame 212 and the forehead support 216, therebyreducing manufacturing costs and the need for inventory. Thus, fourlocking clips 228 are used, two locking clips 228 for the frame 212 andtwo locking clips 228 for the forehead support 216. In use, upper strapsof a headgear assembly would be removably connected to the locking clips228 for the forehead support 216 and lower straps of the headgearassembly would be removably connected to locking clips 228 for the frame212.

It can thus be appreciated that the aspects of the present inventionhave been fully and effectively accomplished. The foregoing specificembodiments have been provided to illustrate the structural andfunctional principles of the present invention, and are not intended tobe limiting. To the contrary, the present invention is intended toencompass all modifications, alterations and substitutions within thespirit and scope of the detailed description.

1-14. (canceled)
 15. A locking clip for removably coupling a frame and aheadgear assembly of a respiratory mask assembly for deliveringbreathable gas to a patient, the locking clip comprising: a main bodyproviding a front portion and a rear portion, the front portion adaptedto be removably coupled with the frame and the rear portion adapted tobe removably coupled to the headgear assembly, wherein the rear portionincludes a cross bar that forms an opening through which a strap of theheadgear assembly can pass and be removably coupled with the cross bar,and the front portion includes a pair of resiliently flexible springarms that are flexible within the plane of the main body, wherein thefront portion and rear portion are disposed at an angle with respect toone another.
 16. The locking clip according to claim 15, wherein eachspring arm includes a locking tab at a free end thereof, the locking tabconfigured to be inserted into a slot of the frame and interlocked witha locking flange provided within the slot to removably couple thelocking clip to the frame.
 17. The locking clip according to claim 15,wherein the locking clip includes a central support tab that is insertedinto a slot of the frame when the locking clip and frame are removablycoupled so as to prevent relative movement between the locking clip andthe frame.
 18. The locking clip according to claim 17, wherein centralsupport tab is positioned between the pair of spring arms and has alength that is greater than a length of each of the spring arms.
 19. Thelocking clip according to claim 18, wherein the central support tabincludes a groove that receives a protrusion provided in the slot whenthe locking clip and frame are removably coupled to one another.
 20. Thelocking clip according to claim 19, wherein the groove has a length thatis at least half a length of the central support tab.
 21. The lockingclip according to claim 19, wherein a force applied to one of the pairof spring arms is not be transferred to the other of the pair of springarms due to the engagement between the groove of the central support taband the protrusion of the slot.
 22. The locking clip according to claim17, wherein the central support tab has a height that is greater than aheight of a front portion of the at least one spring arm.
 23. Thelocking clip according to claim 15, wherein the locking clip isconfigured to allow the patient to grasp the same between the thumb andforefinger of the patient.
 24. A respiratory mask assembly fordelivering breathable gas to a patient, comprising: a frame having amain body and a side frame member provided on each lateral side of themain body, at least one of the side frame members including anintegrally formed locking clip receiver assembly; and at least onelocking clip having a main body providing a front portion and a rearportion, the front portion adapted to be removably coupled with the atleast one locking clip receiver assembly and the rear portion adapted tobe removably coupled to a headgear assembly, wherein the front portionand rear portion of the at least one locking clip are disposed at anangle with respect to one another.
 25. A respiratory mask assemblyaccording to claim 24, wherein the front portion is generally alignedwith the at least one locking clip receiver assembly when the frontportion is removably coupled with the at least one locking clip receiverassembly and the rear portion is angled with respect to the frontportion such that the rear portion extends towards the patient's facewhen the mask assembly is secured to the patient's face.
 26. Arespiratory mask assembly according to claim 24, wherein the rearportion of the locking clip includes a cross bar that forms an openingthrough which a strap of the headgear assembly can pass and be removablycoupled with the cross bar, and the front portion of the locking clipincludes at least one resiliently flexible spring arm that is flexiblewithin the plane of the main body. 27-31. (canceled)